T-GENVIH-003 LTFU (Long Term Follow Up) Study
Study Details
Study Description
Brief Summary
The T-GENVIH-003 study will collect additional, longer term performance data of Gentrix® Surgical Matrix used for reinforcement of ventral hernia repairs from a subset population (i.e., the twenty-one minimally invasive surgical approach cases) from the prior T-GENVIH-002 study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The purpose of this study is to collect additional safety data and demonstrate the performance of Integra Gentrix® Surgical Matrix for reinforcement of ventral hernia repairs from a sub-population of twenty-one participants from the previous T-GENVIH-002 study, specifically those with laparoscopic or robotic repair. Prospective data will be collected via a one-off study follow-up visit and assessed for later post-operative surgical site events and complications in the post-operative period from the last timepoint of data collection in T-GENVIH-002 to present.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Prospective Analysis of Minimally Invasive Surgical Approach (i.e., laparoscopic or robotic) Collection of performance data for twenty-one subjects having prior minimally invasive surgical approach for ventral hernia repair (i.e., laparoscopic or robotic) from the previous T-GENVIH-002 study last data collection time-point (1-yr post-op) to present (prospective analysis), not previously reported. |
Device: Integra® Gentrix® Surgical Matrix
Integra® Gentrix® Surgical Matrix is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery.
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Outcome Measures
Primary Outcome Measures
- Clinically Confirmed Recurrence [1 year to present]
1. Incidence of clinically confirmed recurrence of the primary hernia to date, including not previously reported in T-GENVIH-002 study.
Secondary Outcome Measures
- Self-Reported Recurrence [1 year to present]
Incidence of self-reported recurrence (i.e., bulge) of the primary hernia to date, including not previously reported in T-GENVIH-002 study.
- Incidence of Surgical Site Occurrences requiring Procedural Intervention (SSOPI) [1 year to present]
Incidence of Surgical Site Occurrences requiring Procedural Intervention (SSOPI) of the primary hernia repair to date, including not previously reported in T-GENVIH-002.
- Incidence of Surgical Site Occurrences (SSOs) [1 year to present]
Incidence of Surgical Site Occurrences (SSOs) of the primary hernia repair to date (seroma, abscess, dehiscence, hematoma, wound necrosis, ileus, fistula, delayed wound healing), including not previously reported in T-GENVIH-002 study.
- Incidence of Surgical Site Infections (SSIs) [1 year to present]
Incidence of Surgical Site Infections (SSIs) post primary hernia repair to date, including not previously reported in T-GENVIH-002 study.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient was a subject in the T-GENVIH-002 study and underwent minimally invasive (i.e., laparoscopic or robotic) abdominal wall reconstruction for a primary hernia using Integra® Gentrix® Surgical Matrix.
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Subject has participated in the informed consent process and signed a study-specific informed consent document.
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Subject is fluent in US English or US Spanish language.
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Subject is willing to complete an e-consent and phone or in-office visit.
Exclusion Criteria:
- Not applicable.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Surgical Healing Arts | Fort Myers | Florida | United States | 33912 |
Sponsors and Collaborators
- Integra LifeSciences Corporation
Investigators
- Study Director: Adam Young, PhD PMP, Integra LifeSciences Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- T-GENVIH-003